van Klaveren David, Vergouwe Yvonne, Farooq Vasim, Serruys Patrick W, Steyerberg Ewout W
Department of Public Health, Erasmus MC: University Medical Center Rotterdam, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.
Department of Public Health, Erasmus MC: University Medical Center Rotterdam, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.
J Clin Epidemiol. 2015 Nov;68(11):1366-74. doi: 10.1016/j.jclinepi.2015.02.012. Epub 2015 Feb 27.
We aimed to compare modeling approaches to estimate the individual survival benefit of treatment with either coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) for patients with complex coronary artery disease.
We estimated survival with Cox regression models that included the treatment variable (CABG/PCI) interacting with either an internally developed overall prognostic index (PI) or with individual prognostic factors. We analyzed data of patients who were randomized in the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery trial (1,800 patients, 178 deaths).
A negligible interaction with the PI (P = 0.51) led to 4-year survival estimates in favor of CABG for all patients. In contrast, individual interactions indicated substantial relative treatment effect heterogeneity (overall interaction P = 0.004), and estimates of 4-year survival were numerically in favor of CABG for 1,275 of 1,800 patients (71%; 519 with 95% confidence). To test the more complex model with individual interactions, we first used penalized regression, resulting in smaller but largely consistent individual estimates of the survival difference between CABG and PCI. Second, strong treatment interactions were confirmed at external validation in 2,891 patients from a multinational registry.
Modeling strategies that omit interactions may result in misleading estimates of absolute treatment benefit for individual patients with the potential hazard of suboptimal decision making.
我们旨在比较不同的建模方法，以评估冠状动脉搭桥术（CABG）或经皮冠状动脉介入治疗（PCI）对复杂冠状动脉疾病患者的个体生存获益。
我们使用Cox回归模型估计生存率，该模型纳入了治疗变量（CABG/PCI）与内部开发的总体预后指数（PI）或个体预后因素的交互作用。我们分析了在紫杉醇涂层支架与心脏手术协同试验中随机分组的患者数据（1800例患者，178例死亡）。
与PI的交互作用可忽略不计（P = 0.51），这使得所有患者4年生存率的估计结果有利于CABG。相比之下，个体交互作用表明治疗的相对效果存在显著异质性（总体交互作用P = 0.004），1800例患者中有1275例（71%；519例具有95%置信区间）的4年生存率估计在数值上有利于CABG。为了检验具有个体交互作用的更复杂模型，我们首先使用了惩罚回归，结果得到了CABG和PCI之间生存差异的更小但基本一致的个体估计值。其次，在来自多国登记处的2891例患者的外部验证中证实了强烈的治疗交互作用。
忽略交互作用的建模策略可能会导致对个体患者绝对治疗获益的误导性估计，并可能带来次优决策的潜在风险。
